Sterile instrument package



June 14, 1966 R. M. GROSSMAN 3,255,880

STERILE INSTRUMENT PACKAGE Filed Aug. 25, 1964 INVENTOR.

ROBERT M. GROSSMIAN ATT'YS United States Patent 3,255,880 STERILEINSTRUMENT PACKAGE Robert M. Grossman, Milledgeville, Ga., assignor toMe- Gaw Laboratories, Inc., Milledgeville, Ga., a corporation ofDelaware Filed Aug. 25, 1964, Ser. No. 391,872 3 Claims. (Cl. 20678)This invention relates to a sterile instrument package, and morespecifically, to a container for sterile instruments such as, forexample, blood administration sets and other devices suitable formedical or surgical use.

The main object of the present invention is to provide an inexpensiveand disposable instrument container which effectively maintains itscontents in sterile condition and which may be quickly and easily openedfor removal of those contents. Ease of opening is particularly importantwhere the sterile instrument is of a type which may be required foremergency use but such case must not be achieved at the risk of aconstruction which might result in premature exposure and possiblecontamination of the instrument by bacteria or foreign particles.

Another object is to provide a container which is es-. sentiallytamper-proof; that is, one which for all practical purposes cannot berescaled after it has been once opened. In this connection, it is aspecific object to provide a container construction in which an evenpartial prior opening of the package may be readily ascertained by auser.

A further object of the invention is to provide an instrument packagewhich permits removal of the sterile instrument contained thereinwithout danger that the instrument, as it is-being removed, will"contact non-sterile or contaminating surfaces or edges of the containeritself.

A still further object is to provide a container which, upon opening,provides an enlarged rem-oval opening for access to and removal of theinstrument, thereby permitting the instrument to be lifted from thecontainer rather than pulled or pushed therefrom.

Other objects will appear from the specification and drawings in which:

FIGURE 1 is a perspective view of the instrument package embodying thepresent invention;

FIGURE 2 is a perspective view of the underside of the package;

FIGURE 3 is an enlarged fragmentary perspective view of a corner portionof the package illustrating the structure in the process of beingopened;

FIGURE 4 is a transverse vertical sectional view taken along line 4-4 ofFIGURE 1;

FIGURE 5 is a vertical sectional view taken along line 55 of FIGURE 1and illustrating in broken line the package in the process of beingopened.

In the embodiment of the invention illustrated in the drawing, thenumeral generally designates an instrument package comprising acontainer 11 and a sterile instrument 12 (shown in broken line) therein.In the illustration given, the sterile instrument consists of aconventional administration set for parenteral fluids, the set includingthe usual plastic tubing, drip housing, sheathed needle adapter, andclamp. Since all of these components are entirely conventional and sincethe administration set 12 is simply an example of the type of instrumentwhich the container 11 is particularly adapted to protect and maintainin sterile condition, a further description of the administration setitself is believed unnecessary herein.

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Container 11 consists essentially of a transparent plastic shell 13 anda backing panel 14. The shell may be' molded from any suitable plasticmaterial such as polyvinyl chloride, polyvinyl acetate, or polyvinylchloride acetate. As shown in the drawings, the shell is molded toprovide a cavity 15 defined by integral top wall 13a and side Wall 13b.The cavity as defined by the shell is open at its bottom but is sealedby the backing panel 14 which will be described in detail hereinafter.As shown most clearly in FIGURES 4 and 5, shell 13 is also provided witha laterally projecting skirt portion which extends completely about theperimeter of the cavitys bottom opening.

The backing panel 14 is laminated from paper or other suitable materialhaving similar properties of flexibility, bendability and tearabilityand is composed of an upper sheet or inner layer 14a and a lower sheetor outer layer 14b. The opposing surfaces of the two sheets are securedtogether by any suitable adhesive and the undersurface of perimetricskirt portion 130 is similarly secured to the upper surface of sheet14a. If desired, the upper surface of sheet 14a may be plastic coatedand the skirt portion of the shell may then be heat-sealed thereto. Theplastic coating of the upper sheet not only facilitates the joining ofthe backing to the shell but also assists in maintaining the contents ofthe container in sterile condition.

Referring in particular to FIGURES 24, it will be noted that the backingpanel is die cut to form an interconnected outer frame portion 16, aclosure member 17 and an access flap 18. The closure member 17 is ofsubstantial size, being only slightly smaller in its dimensions thanthose of cavity 15.

To form the closure member, the top sheet 14a is die cut along line 19to define an inner closure portion and bottom sheet 14b is die cut alongline 20 to define an outer closure portion, the two lines being ofsubstantially the same configuration but being spaced laterally apart todefine therebetween a narrow zone of adhesive connection between theclosure member 17 and the frame portion 16 of the backing panel.Specifically, the upper line of die cutting is spaced inwardly of lowerline 20 with the result that the closure member is held in place by anarrow perimetric flange 17a extending outwardly or laterally beneaththe overhanging flange 16a of the backing sheets perimetric frameportion 16. Since the die-cut opening in the upper sheet 14a is smallerthan the opening in lower sheet 14b, the flanges 16a and 17a coact toprevent member 17 from being pushed inwardly into the cavity uponrupture of the adhesive interconnection.

The closure membermay, however, be pulled outwardly or downwardly awayfrom the remainder of the backing panel if sufiicient force is appliedto break the adhesive connection in the narrow zone or band betweenAccess flap 18 is provided in one corner of the backing panel and isdefined by die cut lines 21 in upper 3 sheet 14a and lines 22 in lowersheet 14b, the lines in the respective sheets intersecting the die cutlines 19 and 20 already mentioned. It will be noted, however, thatunlike the die cut lines which define the closure member, the lines 21and 2.2 which define the sides of access flap 18 are reversely arrangedwith lines 21 in the upper sheet being spaced farther apart than lines22 in the lower sheet. The side flanges 18a of the flap therefore extendover (rather than beneath) the flanges 16b of the backing sheets frameportion and, upon the application of inward force against flap 18, theflap may flex inwardly into cavity 15 (FIGURES 3 and shearing theadhesive connection between'the upper and lower sheets in the zonesbetween the upper and lower flanges 18a and 16b and also between thoseportions of flanges 17a and 16a which complete the marginal definitionof the flap.

To remove the contents of the package, a user simply pushes the accessflap inwardly until the adhesive seal between the front and side flangesof the flap is broken and the flap flexes inwardly as indicated inFIGURE 3 and by the broken lines in FIGURE 5. Preferably this step iscarried out with the package in inverted condition as illustrated inFIGURE 2 and with the contents of the package spaced from the flap(FIGURE 1). Since the cavity is substantially larger than the instrumentpackaged within the container, a shifting of the instrument to one endof the container may be accomplished simply by tipping the container onend before it is inverted and the flap 18 is depressed.

After the flap has been pushed inwardly, a user may open the package bymerely inserting a finger through the flap opening and pulling upwardlyon the closure member of the inverted package. After the adhesiveinterconnection between the overlapping flanges 17a and 16a has beenbroken, the closure member is fully released from the container and itsremoval exposes the instrument supported within shell 13. Sincesubstantially the entire instrument is exposed, it may be easily liftedand removed from the container.

During removal of the instrument from the container, it is likely thatthe instrument will brush the edges of flange 16a which defines thecontainer opening. Since the surfaces and edges of the flange, prior toremoval of closure member 17, form a part of the interior of thecontainer or constitute adhesive-bearing surfaces between laminations ofthe backing sheet, such surfaces and edges are in the same sterilecondition as the contents and interior surfaces of the package.Therefore, contact between the instrument and such surfaces or edges asthe instrument is removed will not result in its contamination.

It is believed apparent from the foregoing that the containerconstruction of the present invention permits quick removal of a sterileinstrument when emergency use of that instrument is required.Furthermore, such removal may be accomplished easily and rapidly withoutdangerof contaminating the instrument during the removal process.

While in the foregoing I have disclosed an embodiment of the inventionin considerable detail for purposes of illustration, it will beunderstood by those skilled in the art that many of these details may bevaried without departing from the spirit and scope of the invention.

I claim:

1. In an instrument package, a container comprising a transparentplastic shell defining a cavity open at its lower end, a bottom panel offlexible sheet material sealingly secured to said shell about the bottomof said cavity and being die cut to define an integral and removableclosure member, said panel comprising upper and lower sheets adhesivelysecured together, said upper sheet being die cut to define the outlineof an enlarged opening and the'upper portion of said closure member, andsaid lower sheet being die cut along a line conforming generally withsaid outline but being spaced outwardly therefrom to define a lowerportion of said closure member of greater area than said upper portion,said die cut lines defining therebetween a narrow zone of adhesiveinterconnection between said closure member and the remainder of saidbottom panel, and access means provided by said bottom panel forpermitting access to the cavity of said shell for pulling said closuremember outwardly away from the remainder of said bottom panel, saidaccess means comprising a flap formed in said bottom panel as anintegral portion thereof disposed outwardly beyond said closure member,said flap having its sides defined by die-cut side-forming lines in theupper and lower sheets of said bottom panel intersecting at spacedpoints the die cut lines defining said closure member, portions of thedie cut lines for said closure member also defining between said pointsof intersection the end of said flap, the die-cut side-forming lines inthe lower sheet being spaced closer to each other than the side-forminglines in the upper sheet to define along opposite sides of said flapnarrow zones of adhesive interconnection between the sides of the flapand the remainder of the bottom panel, whereby, an access opening isformed by urging said flap upwardly into said cavity to break theadhesive interconnections along the sides and end of the flap to exposean edge portion of said closure member, thereby facilitating removal ofsaid closure member.

2. A laminated panel for containers comprising outer and inner layers offlexible sheet material adhesively joined together and being strippablefrom each other, said inner layer having a continuous die out linetherethrough defining an inner closure portion, said outer layer havinga die out line therethrough and spaced outwardly from the line of saidinner layer and defining an outer closure portion, said inner and outerclosure portions together constituting a removable closure member, andan access flap formed as an integral part of said panel and disposedbeyond the periphery of said closure member, said access flap havingside edges and having an end edge co-extensive with a portion of theperiphery of said closure member, said side edges being defined byspaced pairs of inner and outer die cut lines in the inner and outerlayers of said panel extending toward the periphery of said closuremember, said inner pair of die cut lines terminating at the die out linedefining said outer closure portion and said outer pair of die cut linesterminating at the line defining said inner closure portion, said innerpair of lines being spaced substantially closer together than said outerpair of lines, whereby, an access opening may be formed by urging saidflap inwardly to expose a portion of the periphery of said closuremember, and thereafter said closure member may be gripped through saidaccess opening and pulled outwardly from the remainder of said panel.

3. A laminated panel for containers comprising a closure member and aframe portion thereabout, both formed as integral parts of said panel;said closure member and frame portion having overlapping flanges definedby die cut lines spaced laterally from each other in said outer andinner layers, respectively; the flange of said closure member beingdisposed outwardly of the flange of said frame portion; an access flapformed in said frame portion; said flap having sides and having an endco-extensive with a portion of the periphery of said closure member; thesides of said flap and the remainder of said frame portion havingoverlapping side flanges defined by diecut lines spaced laterally fromeach other-in said inner and outer layers, respectively; the sideflanges of said flap being disposed inwardly of the side flanges of saidremainder of said frame portion, and said end of said flap having aflange disposedinwardly of a portion of the flange of said closuremember; whereby, access to a peripheral portion of said closure memberfor outward removal of the same is achieved by urging said flap inwardlyto strip the end flange of said flap from the flange of said closuremember and thereby expose a portion of the 5v 1 6 periphery of saidclosure member through the access 2,993,590 7/1961 Denton. opening soformed. 3,004,661 10/1961 Schumann 206-78 FOREIGN PATENTS ReferencesCited by the Examiner 5 673 49 4 6/1952 Great Britain UNITED STATESPATENTS THERON E CONDON P E 1,773,553 8/1930 Taylor et a1. 229-512,813,624 11/1957 Phipps 206-78 GEORGE E-LOWRANCEEWWW- 2,858,060 10/1958Kuechler 22951 J. M. CASKIE, Assistant Examiner.

1. IN AN INSTRUMENT PACKAGE, A CONTAINER COMPRISING A TRANSPARENTPLASTIC SHELL DEFINING A CAVITY OPEN AT ITS LOWER END, A BOTTOM PANEL OFFLEXIBLE SHEET MATERIAL SEALINGLY SECURED TO SAID SHELL ABOUT THE BOTTOMOF SAID CAVITY AND BEING DIE CUT TO DEFINE AN INTEGRAL AND REMOVABLECLOSURE MEMBER, AND PANEL COMPRISING UPPER AND LOWER SHEETS ADHESIVELYSECURED TOGETHER, SAID UPPER SHEET BEING DIE CUT TO DEFINE THE OUTLINEOF AN ENLARGED OPENING AND THE UPPER PORTION OF SAID CLOSURE MEMBER, ANDSAID LOWER SHEET BEING DID CUT ALONG A LINE CONFORMING GENERALLY WITHSAID OUTLINE BUT BEING SPACED OUTWARDLY THEREFROM TO DEFINE A LOWERPORTION OF SAID CLOSURE MEMBER OF GREATER AREA THAN SAID UPPER PORTION,SAID DIE CUT LINES DEFINING THEREBETWEEN A NARROW ZONE OF ADHESIVEINTERCONNECTION BETWEEN SAID CLOSURE MEMBER AND THE REMAINDER OF SAIDBOTTOM PANEL, AND ACCESS MEANS PROVIDED BY SAID BOTTOM PANEL FORPERMITTING ACCESS TO THE CAVITY OF SAID SHELL FOR PULLING SAID CLOSUREMEMBER OUTWARDLY AWAY FROM THE REMAINDER OF SAID BOTTOM PANEL, SAIDACCESS MEANS COMPRISING A FLAT FORMED IN SAID BOTTOM PANEL AS ANINTEGRAL PORTION THEREOF DISPOSED OUTWARDLY BEYOND SAID CLOSURE MEMBER,SAID FLAP HAVING ITS SIDES DEFINED BY DIE-CUT SIDE-FORMING LINES IN THEUPPER AND LOWER SHEETS OF SAID BOTTOM PANEL INTERSECTING AT SPACEDPOINTS THE DIE CUT LINES DEFINING SAID CLOSURE MEMBER, PORTIONS OF THEDIE CUT LINES FOR SAID CLOSURE MEMBER ALSO DEFINING BETWEEN SAID POINTSOF INTERSECTION THE END OF SAID FLAP, THE DIE-CUT SIDE-FORMING LINES INTHE LOWER SHEET BEING SPACED CLOSER TO EACH OTHER THAN THE SIDE-FORMINGLINES IN THE UPPER SHEET TO DEFINE ALONG OPPOSITE SIDES OF SAID FLAPNARROW ZONES OF ADHESIVE INTERCONNECTION BETWEEN THE SIDES OF THE FLAPAND THE REMAINDER OF THE BOTTOM PANEL, WHEREBY, AN ACCESS OPENING ISFORMED BY URGING SAID FLAP UPWARDLY INTO SAID CAVITY TO BREAK THEADHESIVE INTERCONNECTIONS ALONG THE SIDES AND END OF THE FLAP TO EXPOSEAN EDGE PORTION OF SAID CLOSURE MEMBER, THEREBY FACILITATING REMOVAL OFSAID CLOSURE MEMBER.